FDA-Device2012-10-03Class II
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Siemens Medical Solutions USA, Inc
Hazard
When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids).
Sold states
Nationwide Distribution - USA including Washington, DC and AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and Puerto Rico.
Affected count
370
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2464-2012Don't want to check this manually?
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